HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 11/18
EN
Official Journal of the European Union
15.1.2011
COMMISSION REGULATION (EU) No 26/2011
of 14 January 2011
concerning the authorisation of vitamin E as a feed additive for all animal species
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
European
Food
Safety
Authority
(the
Authority)
concluded in its opinion of 25 May 2010 that, under
the proposed conditions of use, vitamin E does not have
an adverse effect on animal health, consumer health or
the environment ( 3 ). It also verified the report on the
Having regard to the Treaty on the Functioning of the European
method of analysis of the feed additive in feed
Union,
submitted by the Community Reference Laboratory set
up by Regulation (EC) No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(5) The
assessment
of
vitamin
E
shows
that
the
conditions
2003 on additives for use in animal nutrition (
for authorisation, as provided for in Article 5 of Regu

1 ), and in
particular Article 9(2) thereof,
lation (EC) No 1831/2003, are satisfied. Accordingly, the
use of that additive should be authorised as specified in
the Annex to this Regulation.
Whereas:
(6)
Since the modifications on the conditions of the au-
thorisation are not related to safety reasons, it is appro
priate to allow a transitional period for the disposal of
existing stocks of the premixtures and compound feed.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
au-
thorisation of additives for use in animal nutrition and
for the grounds and procedures for granting such au-
thorisation. Article 10 of that Regulation provides for
the re-evaluation of additives authorised pursuant to
Council Directive 70/524/EEC (
(7) The
measures
provided
for
in
this
Regulation
are
in

2 ).
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(2) Vitamin
E
was
authorised
without
time
limit
as
a
feed
additive for use in all animal species by Directive
70/524/EEC as part of the group ‘Vitamins, pro-
HAS ADOPTED THIS REGULATION:
vitamins and chemically well-defined substances having
similar effect’. That additive was subsequently entered in
the Register of feed additives as an existing product, in
accordance with Article 10(1) of Regulation (EC) No
1831/2003.
Article 1
The preparations specified in the Annex, belonging to the
additive category ‘nutritional additives’ are authorised as
additives in animal nutrition subject to the conditions laid
down in that Annex.
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 of that Regu
lation, an application was submitted for the re-evaluation
of vitamin E as a feed additive for all animal species,
requesting that additive to be classified in the additive
Article 2
category ‘nutritional additives’. The application was
accompanied by the particulars and documents required
Feed containing vitamin E labelled in accordance with Directive
under Article 7(3) of Regulation (EC) No 1831/2003.
70/524/EEC or Regulation (EC) No 1831/2003 may continue to
be placed on the market and used until stocks are exhausted.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) EFSA Journal 2010; 8(6):1635 (Summary).

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EN
15.1.2011 Official
Journal
of
the
European
Union L
11/19
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 14 January 2011.
For the Commission
The President
José Manuel BARROSO

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L 11/20
ANNEX
Identification
Species or
number of
Additive Chemical
formula,
description,
methods
of
analysis
category of
Maximum
Minimum
Maximum
the additive
animal
age
content
content
Other provisions
End of period of
authorisation
Nutritional additives: Vitamins, pro-vitamins and chemically well-defined substances having similar effect
EN

3a700 Vitamin
E/all-rac-alpha-tocopheryl
Active substance
All animal
—
—
— 1.
If
vitamin
E
content
is
mentioned
4 February 2021
acetate
species
in the labelling, the following
all-rac-alpha-tocopheryl acetate: C 31H 52O 3
equivalencies for the units of
CAS No 7695-91-2
measurement of the contents
shall be used:
Purity criteria: all-rac-alpha-tocopheryl
acetate > 93 %
— 1 mg all-rac-alpha-tocopheryl
acetate = 1 IU
Methods of analysis
Off
— 1 mg RRR-alpha-tocopherol =
1. For the determination of vitamin E
1,49 IU
icial
(oil form) in feed additives: European
Jour
Pharmacopoeia EP-0439.
— 1 mg RRR-alpha-tocopheryl
acetate = 1,36 IU
nal
2. For the determination of vitamin E
(powder form) in feed additives:
2. Vitamin E may be used also via
of
European Pharmacopoeia EP-0691.
water for drinking.
the
3. For the determination of the level of
European
authorised vitamin E in feed: Commission
Regulation (EC) No 152/2009 (1 ).
Union
Vitamin E/RRR alpha tocopheryl Active substance
acetate
RRR alpha tocopheryl acetate: C 31H 52O 3
CAS No 58-95-7
Purity criteria: RRR-alpha-tocopheryl acetate
> 40 %
Methods of analysis
1. For the determination of vitamin E
(oil form) in feed additives: European
Pharmacopoeia EP-1257.
2. For the determination of vitamin E
(powder form) in feed additives:
European Pharmacopoeia EP-1801.
15.1.2011
3. For the determination of the level of
authorised vitamin E in feed: Commission
Regulation (EC) No 152/2009.

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15.1.2011 Off
Identification
Species or
number of
Additive Chemical
formula,
description,
methods
of
analysis
category of
Maximum
Minimum
Maximum
the additive
animal
age
content
content
Other provisions
End of period of
authorisation
Vitamin E/RRR alpha tocopherol Active
substance
RRR alpha tocopherol: C 29H 50O 2
CAS No 59-02-9
EN

Purity criteria: RRR-alpha-tocopherol > 67 %
Methods of analysis
1. For the determination of vitamin E
(oil form) in feed additives: European
Pharmacopoeia EP-1256.
2. For the determination of vitamin E
(powder form) in feed additives:
European Pharmacopoeia EP-1801.
icial
3. For the determination of the level of
authorised vitamin E in feed: Commission
Jour
Regulation (EC) No 152/2009.
nal
(1 ) OJ L 54, 26.2.2009, p. 1.
of
the
European
Union
L
11/21

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